B-Cell Receptor IGH Gene Rearrangement, PCR
Test Summary
This assay, which interrogates the immunoglobulin heavy chain gene (IGH) by a PCR method based on the BIOMED-2 consensus, is useful for establishing clonality of B-cell neoplasms and in the identification of minimal residual disease or early recurrence in patients with a previous diagnosis of a B-cell neoplasm. It can be used in association with the immunoglobulin kappa light chain (IGK test code 90363, or IDH/IGK combo test code 91635), since false-negative results can occur in up to 10-20% of B-cell malignancies when testing for IGH only. The highest rates of non-detectable IGH clonal rearrangements are in IGV- mutated B-cell neoplasms such as follicular lymphoma and plasma cell neoplasms and in B-lymphoblastic leukemia/lymphoma due to absent or incomplete B-cell receptor rearrangements.
Aliases
- N/A
Specimen Collection
Special Instructions
N/A
Preferred Specimen
5 mL whole blood or 3 mL bone marrow aspirate collected in an EDTA (lavender-top) tube • 8 unstained positively charged slides
Minimum Volume
3 mL whole blood • 1 mL bone marrow aspirate • 8 slides • 1 block
Instructions
Do not reject specimens, send to laboratory for screening.
8 unstained sections on glass slides labeled with surgical case number (pathology report required, indicate if fixative is not formalin) Please include pathology report for frozen tissue and FFPE cases (partial/preliminary reports acceptable).
Needle washings (acceptable): in alcohol based fixative (eg. CytoLyt) are acceptable).
8 unstained sections on glass slides labeled with surgical case number (pathology report required, indicate if fixative is not formalin) Please include pathology report for frozen tissue and FFPE cases (partial/preliminary reports acceptable).
Needle washings (acceptable): in alcohol based fixative (eg. CytoLyt) are acceptable).
Patient Preparation
N/A
Storage
N/A
Transport Temperature
Fresh tissue: Frozen
All other specimens: Room temperature
All other specimens: Room temperature
Specimen Stability
- Whole blood/Bone marrow aspirate
- Room temperature: 7 days
- Refrigerated: 7 days
- Frozen: Unacceptable
- FFPE/Slides
- Room temperature: 5 years
- Refrigerated: 5 years
- Frozen: Unac
Limitations
N/A
Other Acceptable Specimens
Whole blood or bone marrow aspirate collected in: a sodium heparin (green-top) tube • Formalin-fixed, paraffin-embedded tissue • Fresh tissue • Tissues in formalin fixative or RPMI
Unacceptable Specimens
N/A
Order Code
BCRIGH
EPIC (Premier) Code
LAB5392
Includes
Test includes pathologist interpretation
CPT Code
- 81261
- 84999 (HCPCS: G0452)
Billing Code
- 670577
- 670578
CPT Statement
Methodology
Polymerase Chain Reaction (PCR) • Fragment Analysis
FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Physician Attestation of Informed Consent
N/A
Testing Laboratory
Quest Diagnostics Nichols Institute
33608 Ortega Highway
San Juan Capistrano CA, 92675
33608 Ortega Highway
San Juan Capistrano CA, 92675
Department
Reference Testing
Reference Range
See Laboratory Report
Setup Schedule / Expected Turnaround Time
Daily; Report available: 5 days
Specimen Collection
Special Instructions
N/A
Preferred Specimen
5 mL whole blood or 3 mL bone marrow aspirate collected in an EDTA (lavender-top) tube • 8 unstained positively charged slides
Minimum Volume
3 mL whole blood • 1 mL bone marrow aspirate • 8 slides • 1 block
Instructions
Do not reject specimens, send to laboratory for screening.
8 unstained sections on glass slides labeled with surgical case number (pathology report required, indicate if fixative is not formalin) Please include pathology report for frozen tissue and FFPE cases (partial/preliminary reports acceptable).
Needle washings (acceptable): in alcohol based fixative (eg. CytoLyt) are acceptable).
8 unstained sections on glass slides labeled with surgical case number (pathology report required, indicate if fixative is not formalin) Please include pathology report for frozen tissue and FFPE cases (partial/preliminary reports acceptable).
Needle washings (acceptable): in alcohol based fixative (eg. CytoLyt) are acceptable).
Patient Preparation
N/A
Storage
N/A
Transport Temperature
Fresh tissue: Frozen
All other specimens: Room temperature
All other specimens: Room temperature
Specimen Stability
- Whole blood/Bone marrow aspirate
- Room temperature: 7 days
- Refrigerated: 7 days
- Frozen: Unacceptable
- FFPE/Slides
- Room temperature: 5 years
- Refrigerated: 5 years
- Frozen: Unac
Limitations
N/A
Other Acceptable Specimens
Whole blood or bone marrow aspirate collected in: a sodium heparin (green-top) tube • Formalin-fixed, paraffin-embedded tissue • Fresh tissue • Tissues in formalin fixative or RPMI
Unacceptable Specimens
N/A
Result Information
Methodology
Polymerase Chain Reaction (PCR) • Fragment Analysis
Testing Laboratory
N/A
Reference Range
See Laboratory Report
Setup Schedule / Expected Turnaround Time
Daily; Report available: 5 days